Devices and methods to improve efficacy and efficiency of locating the sacral foramina during sacral neuromodulation procedure

ABSTRACT

A method includes: determining one or more measurements from at least one image of a sacrum of a patient; applying the determined one or more measurements with a guide device; locating the guide device on the patient&#39;s backside using a landmark; and while the guide device is located on the patient&#39;s backside, using the guide device to guide insertion of a medical element into the patient. A device for guiding medical element insertion includes: a main body with a locating feature that references a landmark on a patient; a head that is translatable along the main body in a first direction; and a medical element guide that is translatable along the head in a second direction perpendicular to the first direction, wherein the medical element guide is configured to identify the entry location and angle of insertion of a medical element into the patient.

PRIORITY

This application claims priority to U.S. provisional patent applicationNo. 63/411,904 filed Sep. 30, 2022, and U.S. provisional patentapplication No. 63/331,474 filed Apr. 15, 2022, the contents of both ofwhich are incorporated by reference herein in their entirety.

FIELD OF THE INVENTION

Aspects of the present invention relate generally to medical devices andimplant techniques and, more particularly, to devices and methods toimprove efficacy and efficiency of locating the sacral foramina during asacral neuromodulation procedure.

BACKGROUND

Sacral neuromodulation is a treatment for bladder and bowel dysfunction.Sacral neuromodulation involves implanting a device that providescontrolled electrical stimulation to the sacral S3 spinal nerve in thepatient. Prior to permanent implant, the patient undergoes an evaluationcalled a peripheral nerve evaluation (PNE). The evaluation involves aprocedure of implanting temporary leads into the patient and thenobserving results for a time period such as 3 to 14 days. If resultsmeet clinical goals, then the patient may be a candidate for receivingpermanent implants for sacral neuromodulation.

Current techniques for implanting the leads during the evaluationinvolve identifying palpable bony landmarks on the patient and insertinga foramen needle into the patient based on the location of these bonylandmarks. The objective during this procedure is to insert the foramenneedle through the skin and into the S3 foramen such that an electricalstimulation lead can be provided along the sacral S3 spinal nerve. Theprocedure may be performed with fluoroscopic or other image guidance;however, imaging is not always available. Instead, this procedure ismost often performed in the office setting under local anesthesia andwithout imaging.

When fluoroscopy or other imaging is not used, such as in the officesetting, the physician inserts the foramen needle from outside thepatient's body and into the S3 foramen based on experience and byreferencing the palpable bony landmarks. Because the physician cannotsee the S3 foramen when they are attempting to place the foramen needlethrough the S3 foramen, this procedure involves what is known as a‘blind’ insertion. The use of palpable bony landmarks is based on normalanatomy without consideration for anatomic or pathologic variations.This may lead to improper placement of leads in an office setting andeventual failure of PNE. For example, it is often the case that pluralattempts are required to locate the S3 foramen and successfully insertthe foramen needle through it. Because the procedure is performed underlocal anesthesia, the occurrence of plural needle insertions whileattempting to find the unseen S3 foramen can produce a large amount ofpain in the patient. The pain can be significant enough that somepatients abandon the PNE (and thus sacral neuromodulation altogether)during this procedure without ever having the leads properly placed. Assuch, current techniques may lead to multiple skin puncture sites whichcauses pain in the patient, and may result in abandonment of theprocedure in some cases. Misplaced leads may also lead to a falseclinical outcome and abandonment of an otherwise efficacious treatment.

SUMMARY

Implementations of the invention address the above-noted problems of theprior art by providing devices and methods that improve efficacy andefficiency of locating the sacral foramina during sacral neuromodulationprocedure. Embodiments, include imaging a portion of the patient,identifying internal points of the patient in the imaging, calculatingmeasurements based on the imaging and the identified points,transferring the measurements to a device, placing the device on andexterior to the patient using a locating feature, and guiding a medicalelement (e.g., a foramen needle) into the patient using an element guideof the device. In this manner, implementations of the invention help thephysician more accurately locate the S3 foramen and, thus, provide animprovement over conventional techniques that are less accurate atlocating the S3 foramen during a blind insertion.

In a first aspect of the invention, there is a method comprising:determining one or more measurements from at least one image of a sacrumof a patient; applying the determined one or more measurements with aguide device; locating the guide device on the patient's backside usinga landmark; and while the guide device is located on the patient'sbackside, using the guide device to guide insertion of a medical elementinto the patient.

In another aspect of the invention, there is a device for guidingmedical element insertion, the device comprising: a main body with alocating feature that references a landmark on a patient; a head that istranslatable along the main body in a first direction; a medical elementguide that is translatable along the head in a second directionperpendicular to the first direction, wherein the medical element guideis configured to identify the entry location and angle of insertion of amedical element into the patient.

In another aspect of the invention, there is a computer program productcomprising one or more computer readable storage media having programinstructions collectively stored on the one or more computer readablestorage media. The program instructions are executable to: receive atleast one image of a sacrum of a patient; display the at least oneimage; receive user input defining points of interest in the displayedat least one image; determine one or more measurements for a medicalelement guide based on the points of interest and a predefined dimensionof the medical element guide; and output the determined one or moremeasurements to a user.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Aspects of the present invention are described in the detaileddescription which follows, in reference to the noted plurality ofdrawings by way of non-limiting examples of exemplary embodiments of thepresent invention.

FIG. 1 shows an exemplary partial view of the human anatomy.

FIG. 2 shows a flowchart of an exemplary method in accordance withaspects of the invention.

FIGS. 3A and 3B show an example of a radiopaque landmark device inaccordance with aspects of the invention.

FIG. 4A shows an exemplary X-ray image in which a radiopaque element ofa radiopaque landmark device is visible in accordance with aspects ofthe invention.

FIG. 4B shows an exemplary X-ray image in which an imaging systemautomatically provides a scale indicator in accordance with aspects ofthe invention.

FIGS. 5 and 6 show exemplary implementations of identifying points inthe images and processing the image for measurements in accordance withaspects of the invention.

FIGS. 7A-D show examples of a user interface (UI) of an application on acomputing device in accordance with aspects of the invention.

FIGS. 8A-G show an exemplary needle guide device in accordance withaspects of the invention.

FIG. 9 shows an example of placing a needle guide device on a patientusing a locating feature in accordance with aspects of the invention.

FIG. 10 shows an example of guiding a medical element into the patientusing a needle guide device in accordance with aspects of the invention.

FIGS. 11A-G show an exemplary needle guide device in accordance withaspects of the invention.

FIG. 12 shows an example of a locating element affixed to a patient inaccordance with aspects of the invention.

FIG. 13 shows an example of a locating element affixed to a patient anda needle guide device placed on the patient's back and connected to thelocating element in accordance with aspects of the invention.

FIG. 14 shows an example of needle insertion using the needle guidedevice of FIGS. 11A-F in accordance with aspects of the invention.

FIG. 15 shows a flowchart of an exemplary method in accordance withaspects of the invention.

DETAILED DESCRIPTION

The particulars shown herein are by way of example and for purposes ofillustrative discussion of the embodiments of the present invention onlyand are presented in the cause of providing what is believed to be themost useful and readily understood description of the principles andconceptual aspects of the present invention. In this regard, no attemptis made to show structural details in more detail than is necessary forthe fundamental understanding of aspects of the present invention, thedescription taken with the drawings making apparent to those skilled inthe art how several forms of the present invention may be embodied inpractice.

FIG. 1 shows an exemplary partial view of certain skeletal components ofa human torso 10 including the sacrum 15 at the base of the spine 20,and the coccyx 25 at the base of the sacrum 15. As shown in FIG. 1 , thesacrum includes four sacral foramina numbered 31-34. In FIG. 1 , foramen31 corresponds to the S1 foramen, foramen 32 corresponds to the S2foramen, foramen 33 corresponds to the S3 foramen, and foramen 34corresponds to the S4 foramen. Although only one group is number in FIG.1 , the sacrum 15 includes two groups of foramina 31-34, one group oneach side of the median sacral crest. Implementations of the inventionprovide a system and method for accurately locating a selected one ofthe foramina 31-34 and inserting a needle through the selected one ofthe foramina to access a nerve for implanting a component of a sacralneuromodulation system. Embodiments are described herein with respect tolocating and inserting a foramen needle through the S3 foramen; however,implementations of the invention are not limited to use with the S3foramen.

FIG. 2 shows a flowchart of an exemplary method in accordance withaspects of the present invention. Step 205 includes imaging a portion ofthe patient. Step 210 includes identifying internal points of thepatient in the imaging. Step 215 includes calculating measurements basedon the imaging and the identified points. Step 220 includes transferringthe measurements to a device. Step 225 includes placing the device onand exterior to the patient using a locating feature. Step 230 includesguiding a medical element (e.g., a foramen needle) into the patientusing an element guide of the device. Embodiments implementing thesesteps will become apparent from the following figures and associateddescriptions.

FIGS. 3A and 3B show an example of a radiopaque landmark device 305 thatcan be used with the imaging of step 205. In embodiments, the imagingincludes an X-ray of the lateral plane of the patient showing both thesacrum and coccyx of the patient. The imaging may also include one orboth of the anterior-posterior (AP) or posterior-anterior (PA) planes ofthe same area (i.e., showing the sacrum and coccyx of the patient). Theimaging comprises X-ray imaging in a preferred embodiment; however,other imaging technologies that show and distinguish internal bonestructure of the patient may be used. In embodiments, the radiopaquelandmark device 305 is placed on the patient during the X-ray in thefiled of view of the X-ray. In embodiments, the radiopaque landmarkdevice 305 comprises a radio-transparent housing 310 and a radiopaqueelement 315. The radio-transparent housing 310 is composed of a materialthat is relatively transparent to an X-ray (or whatever imagingtechnology is used). Plastic may be used for the radio-transparenthousing 310, for example. The radiopaque element 315 is composed of amaterial that is relatively opaque to an X-ray (or whatever imagingtechnology is used). Stainless steel may be used for the radiopaqueelement 315, for example. In embodiments, the radiopaque element 315 hasa predefined dimension that is used with the X-ray image(s) to define ascale of the image(s) of the patient. In a particular embodiment, theradiopaque element 315 comprises a sphere of a predefined diameter sothat the radiopaque landmark device 305 can be placed in any orientationon the patient during the imaging.

FIG. 4A shows an exemplary X-ray image 405 in which the radiopaqueelement 315 of the radiopaque landmark device 305 is visible. Becausethe radiopaque element 315 has a predefined diameter, this knownmeasurement of the radiopaque element 315 may be used to define a scalefor the X-ray image 405. Embodiments use this scale when calculatingmeasurements as described herein.

FIG. 4B shows an exemplary X-ray image 410 in which the imaging systemautomatically provides a scale indicator 415. Some imaging systemsinclude an automatic scaling function that provides a scale of theimage. In such systems, embodiments may use the scaling provided by theimaging system and the radiopaque landmark device 305 can be omitted. Inboth alternatives (e.g., using the radiopaque landmark device 305 or theautomatic scaling function), the image is provided with a measurement ofa scale of the image, and this measurement of the scale of the image isused in calculating other measurements as described herein.

FIGS. 5 and 6 show exemplary implementations of identifying points inthe image(s) and processing the image(s) for measurements that can beused at steps 210 and 215, respectively, in accordance with aspects ofthe invention. In embodiments, the image(s) from step 205 are uploadedto a computing device for processing. The computing device (not shown)may comprise a conventional computing device (such as a desktopcomputer, laptop computer, tablet computer, or smartphone, for example)that runs a specialized software (e.g., a proprietary application) inaccordance with aspects of the invention. The application may be part ofa computer program product as described herein. In embodiments, thecomputing device comprises at least a display for displaying images(e.g., X-rays taken at step 205) and a user input mechanism that permitsthe user to identify points in a displayed image. The display and userinput mechanism may be combined in a touchscreen display, for example,that can display an image and receive user touch input defining pointsof interest in the image. The display and user input mechanism may beseparate, for example, such as a display screen that displays an imageand a mouse or trackball that controls a pointer (e.g., cursor, arrow,etc.) superimposed on the displayed image, and a button the user maydepress to provide define a current location of the pointer on the imageas a point of interest in the image.

In accordance with aspects of the invention, identifying points in theimage at step 210 includes importing the one or more images from step205 into the application running on the computing device. Inembodiments, the application establishes a scale of the image(s) usingeither the predefined dimension of the radiopaque element 315 in theimage(s) or a scale indicator (e.g., such as scale indicator 415)provided with the image(s). Step 210 may optionally comprise theapplication adjusting visual aspects of the image(s), such as contrast,etc. FIG. 5 shows an example of a lateral X-ray image 505 that includesa scale indicator 510 that defines a scale of the image 505.

With continued reference to FIG. 5 , in accordance with aspects of theinvention, the application receives user input via the computing devicewhere the input defines points of interest in the image 505. Inembodiments, there are four points of interest 521, 522, 523, and 524that are defined by user input. The application may provide one or moremessages to the user that prompt the user to provide their input for oneor more of the points of interest. In embodiments, the user providesinput to define the first point of interest 521 at the tip (e.g., distalend) of the coccyx in the image 505. In embodiments, in response toreceiving this input, the application draws a vertical line 525 upwardfrom the first point of interest 521. In embodiments, while the line 525is displayed, the user provides input to define the second point ofinterest 522 at the intersection of the line 525 and the outer surfaceof the skin of the patient. In embodiments, the user provides input todefine the third point of interest 523 at the center of the S3 foramenin the image 505. In embodiments, in response to receiving this input,the application draws a line 526 perpendicular to the sacrum at thirdpoint of interest 523 and upward toward the outer surface of the skin ofthe patient. In embodiments, while the line 526 is displayed, the userprovides input to adjust or confirm that the line 526 is perpendicularto the sacrum and provides input to define the fourth point of interest524 at the intersection of the line 526 and the outer surface of theskin of the patient.

In accordance with aspects of the invention, processing the image formeasurements at step 215 comprises determining a length measurement, anangle measurement, and a depth measurement based on the points ofinterest defined by the user at step 210. In embodiments, theapplication determines the length measurement, the angle measurement,and the depth measurement based on: the coordinates (e.g., X-Y cartesiancoordinates) of each of the points of interest in a coordinate systemdefined for the image; the scale of the image relative to the samecoordinate system; and one or more predefined dimensions of a devicethat will be utilized as a needle guide using the determined lengthmeasurement and angle measurement. In embodiments, the one or morepredefined dimensions of the device include a predefined radius ofcurvature of a main body of the device. In embodiments, the applicationuses this information (e.g., the coordinates, the scale, and thepredefined dimension of the device) with one or more algorithmsprogrammed with geometric relationships to determine: (i) a length of anarc 530 that extends between the second point 522 and the fourth point524 where the arc has the predefined radius of curvature; (ii) an angle535 between the line 526 and a tangent of the arc 530 at the fourthpoint 524; and (iii) a length of the line 526 between the third point523 and the fourth point 524. In embodiments, the determined length ofthe arc 530 between the second point 522 and the fourth point 524comprises the length measurement, the determined angle 535 comprises theangle measurement, and the determined length of the line 526 between thethird point 523 and the fourth point 524 comprises the depthmeasurement. In embodiments, the application outputs the determinedmeasurements to the user, e.g., via display.

FIG. 6 shows an example of a posterior-anterior (PA) X-ray image 605. Inaccordance with aspects of the invention, the application receives userinput via the computing device where the input defines points ofinterest in the image 605. In embodiments, there are two points ofinterest 621 and 622 that are defined by user input. In embodiments, theuser provides input to define the first point of interest 621 at the atthe center of the S3 foramen in the image 505. In embodiments, inresponse to receiving this input, the application draws a line 625 thatintersects the point 621 and is perpendicular to the centerline of thesacrum. In embodiments, while the line 625 is displayed, the userprovides input to define the second point of interest 622 at theintersection of the line 625 and the centerline of the sacrum. In thisexample, the application uses the coordinates of the points 621 and 622to determine a lateral distance between the points 621 and 622. Inembodiments, the application outputs the determined measurement to theuser, e.g., via display.

FIGS. 7A-D show examples of a user interface (UI) of the application ona computing device in accordance with aspects of the invention. In FIGS.7A-D, the computing device 700 comprises a smartphone or tablet computerwith a touchscreen. In FIGS. 7A-D, the computing device runs theapplication (or a web client that accesses a cloud-run version of theapplication) described above with respect to FIGS. 5 and 6 , and theapplication causes the UI to be displayed on the screen of the computingdevice. FIG. 7A shows a login screen 710 of the UI where a user enterstheir credentials to access features of the application. FIG. 7B shows ascreen 720 of the UI showing a posterior-anterior (PA) X-ray image(e.g., image 605 of FIG. 6 ), in which the user may provide the input todefine points of interest (e.g., points 621 and 622 of FIG. 6 ). FIG. 7Cshows a screen 730 of the UI showing a lateral X-ray image (e.g., image505 of FIG. 5 ), in which the user may provide the input to definepoints of interest (e.g., points 521, 522, 523, and 524 of FIG. 5 ).FIG. 7D shows a screen 740 of the UI by which the user may provide inputto configure the device based on the determined measurements (e.g.,“Configure device to match these measurements”) or provide input to editthe points of interest (e.g., “Edit Markers”) in one or both of theimages.

FIGS. 8A and 8B show an exemplary needle guide device 805 in accordancewith aspects of the invention. In embodiments, the device 805 includes amain body 810, a sliding square head 815, and medical element guides820. In embodiments, the device 805 comprises a depending portion 825that extends downward from a bottom surface of the main body 810. Inembodiments, the bottom surface of the main body 810 has a radius ofcurvature 830 that is one of the one or more predefined dimension of thedevice described with respect to FIG. 5 and used in the application todetermine measurements.

In embodiments, the main body 810 comprises a coccyx locating feature(e.g., the depending portion 825) that is used to locate the device 805on to the patient. In embodiments, the coccyx locating feature ispressed against the coccyx while the arced feature is located along themidline defined by the sagittal plane of the patient. In embodiments,the arced feature of the main body 810 is a predefined arc geometry thatis used by the application for determining measurements at step 215. Inembodiments, the sliding square head 815 slides along the main body 810and remains square to the main body 810. In embodiments, the slidingsquare head 815 can be locked at a specific location along the main body810. In embodiments, the main body 810 has measurements included to setthe sliding square head 815 at the location determined by thecalculations and measurements from patient imaging. In embodiments, thesliding square head 815 includes lateral rails that allow for the use ofthe medical element guide 820. In embodiments, the medical element guide820 slides laterally along the sliding square head 815 and remainssquare to the sliding square head 815. The lateral placement can be setbased on imaging measurements or standard practices. The medical elementguide 820 allows for needle placement at various degrees. The medicalelement guide 820 allows the user to fix the needle at a defined anglein use. In embodiments, the medical element guide 820 and the slidingsquare head 815 are also designed to allow removal of the device whileneedles remain with the patient. In embodiments, marks on the needle arealso used to measure the depth of the needle placement. In embodiments,this measurement is generated during image measurements and can be usedto located depth of the foramen needle in the patient.

In accordance with aspects of the invention, the sliding square head 815may be moved translationally relative to the main body 810 in a firstdirection 841 and a second direction 842 opposite the first directionalong a length of the main body 810. In embodiments, the sliding squarehead 815 comprises a locking mechanism 845 that permits a user toselectively lock (e.g., prevent) and unlock (e.g., permit) thetranslational movement of the sliding square head 815 relative to themain body 810. The locking mechanism may comprise a thumb screw or otherconventional or later developed locking mechanism that can be used toselectively lock (e.g., prevent) and unlock (e.g., permit) thetranslational movement of one device sliding along another device. Inembodiments, the main body 810 includes indicia 850 that correspond tounits of the length measurement determined at step 215. In the exampleshown in FIG. 8A, the indicia 850 comprise a scale of millimeters from 0to 180 along the length of the main body 810.

With continued reference to FIG. 8A, in accordance with aspects of theinvention, transferring the measurements to the device at step 220comprises moving the sliding square head 815 to a position on the mainbody 810 such that an indicator 855 of the sliding square head coincideswith a location in the scale of the indicia 850 that matches the lengthmeasurement determined at step 215. In the example of FIG. 5 , thelength measurement is determined to be 136.8 mm. Using this exemplarylength measurement, at step 220 the user would move the sliding squarehead 815 along the main body 810 until the indicator 855 coincides witha location corresponding to the number 136.8 on the scale of the indicia850. In situations where the number of the length measurement does notalign exactly with one of the numbers of the indicia 850, the user mayinterpolate a position for the indicator 855 between two numbers of theindicia 850 that best matches the length measurement. After positioningthe sliding square head 815 on the main body 810 according to the lengthmeasurement, the user locks the sliding square head 815 relative to themain body 810 using the locking mechanism 845.

In the example shown in FIG. 8A, the device 805 includes medical elementguides 820 that may be moved translationally relative to the slidingsquare head 815 in a first direction 861 and a second direction 862opposite the first direction, where the direction of translation of themedical element guides 820 relative to the sliding square head 815 isperpendicular to the direction of translation of the sliding square head815 relative to the main body 810. In embodiments, the device 805comprises respective locking mechanisms that permit a user toselectively lock (e.g., prevent) and unlock (e.g., permit) thetranslational movement of each medical element guide 820 relative to thesliding square head 815. The locking mechanism may comprise a thumbscrew or other conventional or later developed locking mechanism thatcan be used to selectively lock (e.g., prevent) and unlock (e.g.,permit) the translational movement of one device sliding along anotherdevice. Alternative to locking mechanisms, the sliding square head 815and/or the medical element guides 820 may comprise detents that definepredefined locations of the medical element guides 820 on the slidingsquare head 815. In embodiments, each wing of the sliding square head815 includes indicia 865 that correspond to units of the lateraldistance determined at step 215 (e.g., as described at FIG. 6 ). In theexample shown in FIG. 8A, the indicia 865 comprise a scale ofmillimeters from 10 to 40 along the transverse dimension of the slidingsquare head 815.

With continued reference to FIG. 8A, in accordance with aspects of theinvention, transferring the measurements to the device at step 220 maycomprise moving the medical element guides 820 to positions on the wingsof the sliding square head 815 such that a position indicator of eachmedical element guide 820 head coincides with a location in the scale ofthe indicia 865 that matches the lateral distance determined at step215. In the example of FIG. 5 , the lateral distance is determined to be20 mm. Using this exemplary length measurement, at step 220 the userwould move each medical element guide 820 along its wings of the slidingsquare head 815 until a position indicator on the medical element guide820 coincides with a location corresponding to the number 20 in thescale of the indicia 865. In situations where the number of the lateraldistance does not align exactly with one of the numbers of the indicia865, the user may interpolate a position for the indicator between twonumbers of the indicia 850 that best matches the lateral distance. Afterpositioning the medical element guides 820 on the wings of the slidingsquare head 815 according to the lateral distance, the user may lock themedical element guides 820 relative to the sliding square head 815.

With continued reference to FIGS. 8A and 8B, in embodiments each of themedical element guides 820 includes a graduated needle guide 870including plural needle guide slots 875 arranged at different predefinedangles. In embodiments, the different predefined angles are within arange that is most likely to include the determined angle measurement ofmost patients. For example, the different predefined angles are within arange of 90 degrees to 140 degrees with a discrete one of the pluralneedle guide slots 875 arranged at increments of 10 degrees within thisrange. Each respective one of the plural needle guide slots 875 may beprovided with indicia that indicates the angle of the respective one ofthe plural needle guide slots 875. In embodiments, step 220 comprisesselecting one of the plural needle guide slots 875 based on the anglemeasurement determined at step 215. For example, for an anglemeasurement of 106.5 degrees, the user would select the one of theplural needle guide slots 875 that has an angle closest to 106.5degrees. In an example in which the needle guide slots are arranged at10 degree increments between 90 degrees and 140 degrees, the user wouldselect the 110 degrees angle guide slot for an angle measurement of106.5 degrees.

FIG. 8G shows an exemplary embodiment of the device 805′ in which eachof the medical element guides 820′ includes a single needle slot and themedical element guide 820′ is rotatable around an axis that is parallelto the directions defined by 861 and 862 and perpendicular to thedirections defined by 841 and 842 relative to the sliding square head815 to plural different positions that correspond to different insertionangles of a needle into the patient. The plural different positions maycorrespond to different insertion angles in predefined increments of 10degrees, for example. In this manner, the angle adjustment of themedical element guide 820′ may function in the manner of an adjustableprotractor that is affixed to the sliding square head 815. The rotationof the medical element guides 820′ relative to the sliding square head815 may be selectively locked and unlocked using a locking mechanism. Inembodiments, the elements of the device 805′ function in the same manneras those elements of the device 805 with the exception that the medicalelement guide 820′ having a single needle guide that is rotatable todifferent angles and the medical element guide 820 having plural needleguides at different angles.

In the manner described above, measurements determined at step 215 aretransferred to the device 805. In one example, the scales of thedifferent indicia on the device 805 correspond to the scales of thedifferent measurements determined at step 215. In another example, themeasurements determined at step 215 are converted to values within therange of scales of the different indicia on the device 805 usingpredefined conversion formulas. In this manner, the application mayoutput a set of numbers (e.g., the exact measurements or the convertedvalues), and the user may adjust the device based on the numbersprovided in this output.

FIGS. 8C, 8D, 8E, and 8F show views of the device 805 with a foramenneedle 880 in one of the guide slots 875 of one of the medical elementguides 820. As shown in FIGS. 8C-F, the guide slots are open on an outerend so that the medical element guide 820 can be moved away from theforamen needle 880 when the foramen needle 880 is inserted into thepatient body. This permits adjusting the placement of the medicalelement (needle) angle or removing the entire device 805 from thepatient after foramen needles 880 have been inserted using each of themedical element guides 820.

FIG. 9 shows an example of placing the device 805 on the patient using alocating feature in accordance with aspects of the invention. Inembodiments, step 225 described above comprises locating the device ofthe patient using a location feature. In embodiments, after transferringthe measurements to the device 805 at step 220 (e.g., as described withrespect to FIGS. 8A and 8B), the user places the device 805 on thepatient, i.e., the same patient that was imaged at step 205. Inembodiments, placing the device 805 at step 220 comprises positioningthe device 805 on the outer surface of the skin of the patient who is ina prone position with the depending portion 825 of the device positionedadjacent to the coccyx of the patient and the main body 810 of thedevice 805 aligned with the spine of the patient.

FIG. 10 shows an example of guiding a medical element into the patientusing the device 805 in accordance with aspects of the invention. FIG.10 shows the device 805 placed on the patient as described with respectto step 225 and FIG. 9 , e.g., with the device 805 on the outer surfaceof the skin of the patient who is in a prone position, with thedepending portion 825 of the device positioned adjacent to the coccyx 25of the patient, and the main body 810 of the device 805 aligned with thespine of the patient. In embodiments, after transferring themeasurements to the device 805 at step 220 and then placing the device805 on the patient at step 825, step 230 comprises using the device 805placed on the patient as a guide for inserting a needle (e.g., a foramenneedle 880) into the patient. In embodiments, the user starts theforamen needle 880 in the selected one of the needle guide slots 875(e.g., selected based on the angle measurement) and inserts the foramenneedle 880 through this selected guide slot and into the patient. Thelocation and angle of the needle insertion into the patient are definedby the device 805, which has been adjusted based on measurementsdetermined from the location of the S3 foramen and other landmarks inthis patient's imaging. Due to this, the location and angle of theneedle insertion using the inventive method and device has a much higherrate of success of accurately locating the S3 foramen 33 in the patientcompared to conventional blind techniques.

The foramen needle 880 may be provided with indicia that indicate adepth of insertion of the needle into the patient. The user may insertthe foramen needle into the patient using the depth of insertion indiciato determine when the tip of the foramen needle 880 is close to thenerve in the S3 foramen.

In embodiments, after inserting a respective foramen needle on eitherside of the patient in the manner described, the medical element guides820 may be moved inward along the sliding square head 815 away from therespective foramen needles, such that the device 805 may be removed fromthe patient. After inserting the foramen needles in the patient in thismanner, the PNE procedure may proceed in a conventional fashion. Forexample, portions of the foramen needles may be removed and remainingportions of the foramen needles still in the patient may be used toinsert implantable device leads into the patient.

FIGS. 11A-F show aspects of another example of a needle guide device1105 in accordance with aspects of the invention. In embodiments, thedevice 1105 includes a main body 1110, sliding square head 1115, and oneor two medical element guides 1120, all of which operate in a similarmanner as those similarly named elements described with respect to FIGS.8A-F. In embodiments, the device 1105 includes a locating element 1125that is connectable to the main body 1110. In embodiments, the locatingelement 1125 comprises a disc or other shaped structure that is affixedto the patient during the imaging (e.g., step 205). The locating element1125 may be affixed to the patient using adhesive or other methods. Inembodiments, the locating element is affixed to the patient prior toimaging (e.g., at step 205) and remains fixed to the patient throughoutneedle insertion (e.g., at step 230). FIG. 12 shows an example of thelocating element 1125 affixed to the patient. FIG. 11G shows an exampleof the medical element guide 1120 in accordance with aspects of theinvention.

In embodiments, the locating element 1125 comprises a radiopaque portionthat is visible in the imaging. In embodiments, the identifying pointsof interest (e.g., step 210) and processing the image for measurements(e.g., step 215) are performed based on the radiopaque portion of thelocating element 1125 for the first point of interest and landmarkrather than the tip of the coccyx as described at FIG. 5 . Inembodiments that utilize the device 1105, the application is programmedwith geometric relationships that are based on the landmark coordinatesof the locating element 1125 on the patient in the image, thecoordinates of the S3 foramen in the image, and the predefineddimensions of the main body 1110. Using this information, theapplication uses the geometric relationships to determine a lengthmeasurement, an angle measurement, and a depth measurement, e.g., in amanner similar to that described above but with different use definedpoints of interest and with different geometric relationships.

In embodiments, after determining the length measurement, an anglemeasurement, and a depth measurement for the device 1105, the usertransfers these measurements to the device 1105 (e.g., at step 220).This may be performed in a manner similar to the description of step 220with device 805. For example, the application may output numbers thatcorresponds to measurements along the degrees of freedom of the device1105, and the user may adjust the positions of the elements of thedevice 1105 based on these numbers. For example, the application mayoutput a first number that is based on the determined lengthmeasurement, and the user may adjust the position of the sliding squarehead 1115 along the main body 1110 based on this number and based onindicia on the main body 1110.

In embodiments, after adjusting the device 1105 based on the determinedmeasurements, the user places the device on the patient using thelocating feature. In this embodiment, the locating feature comprises thelocating element 1125. In embodiments, the main body 1110 is configuredto connect to the locating element 1125, e.g., via snap fit or otherconnection mechanism. In embodiments, a portion of the main body 1110that connects to the locating element 1125 comprises a locating featureof the device and the locating element 1125 comprises a landmark on thepatient. In embodiments, step 225 comprises placing the device 1105 onthe patient's back while the patient is in a prone position, connectingthe main body 1110 to the locating element 1125 that is already affixedto the patient's back, and aligning the main body with the spine of thepatient. FIG. 13 shows an example of the locating element 1125 affixedto the patient and the device 1105 placed on the patient's back andconnected to the locating element 1125.

In embodiments, after placing the device 1105 on the patient, the userutilizes the device 1105 as a guide for inserting a needle into thepatient. In embodiments, step 230 comprises the user using the device1105 as a guide for inserting a foramen needle 880 into the patient. Ascan be seen in FIG. 11G, the medical element guide 1120 may comprise anelement that defines an aperture and plural angles that the user canselect based on the determined angle measurement. In embodiments, theuser puts the tip of the needle at the aperture at a base of the medicalelement guide 1120 and aligns the foramen needle 880 with a selected oneof plural angles on the medical element guide 1120 based on thedetermined angle measurement. The needle arranged in this manner is theninserted into the patient. FIG. 14 shows an example of needle insertionusing the device 1105 as a guide. The location and angle of the needleinsertion into the patient are defined by the device 1105, which hasbeen adjusted based on measurements determined from the location of theS3 foramen and other landmarks in this patient's imaging. Due to this,the location and angle of the needle insertion using the inventivemethod and device has a much higher rate of success of accuratelylocating the S3 foramen in the patient compared to conventional blindtechniques.

The devices described herein (e.g., devices 805/805′/1105) are notlimited to use with a foramen needle (such as foramen needle 880) andmay be used to guide the insertion of other types of medical elementsinto the patient. For example, the devices may be used to guideinsertion of medical elements including but not limited to foramenneedles, other types of needles, leads, instruments, scopes, etc.

FIG. 15 shows a flowchart of an exemplary method in accordance withaspects of the invention. Block 1505 includes determining one or moremeasurements from at least one image of a sacrum of a patient. In anon-limiting example, the measurements are determined in the mannerdescribed at FIGS. 5 and/or 6 . Block 1510 includes applying thedetermined one or more measurements with a guide device. In anon-limiting example, the applying comprises making one or moreadjustments to the device 805/805′/1105 based on the determined one ormore measurements in the manner described herein. Block 1515 includeslocating the guide device on the patient's backside using a landmark. Innon-limiting examples, the locating may be performed in the mannerdescribed at FIGS. 9-10 or FIGS. 12-14 . In a non-limiting example, thelandmark comprises the patent's coccyx. In a non-limiting example, thelandmark comprises a locating element affixed to the patient. Block 1520includes, while the guide device is located on the patient's backside,using the guide device to guide insertion of a needle into the patient.In non-limiting examples, the guiding insertion may be performed in themanner described at FIG. 10 or FIG. 14 .

As will be understood from the present disclosure a first aspect of theinvention provides for a method comprising: determining one or moremeasurements from at least one image of a sacrum of a patient; applyingthe determined one or more measurements with a guide device; locatingthe guide device on the patient's backside using a landmark; and whilethe guide device is located on the patient's backside, using the guidedevice to guide insertion of a medical element into the patient.

In embodiments of the method, the guide device may be adjustable andapplying the determined one or more measurements with the guide devicemay comprise adjusting the guide device based on the one or moremeasurements.

In embodiments of the method, the landmark comprises the patent'scoccyx.

In embodiments of the method, the landmark comprises a locating elementaffixed to the patient.

In embodiments of the method, the at least one image comprises an imageof a pelvis of the patient in a lateral plane. In embodiments of themethod, the at least one image comprises an image of the pelvis of thepatient in a posterior-anterior plane or an anterior posterior plane. Inembodiments of the method, the at least one image comprises an X-ray ora CT scan.

In embodiments of the method, the one or more measurements aredetermined based on user input defining points of interest in the atleast one image. In embodiments of the method, the points of interest inthe at least one image comprise a location of a foramen in the sacrum.In embodiments of the method, the one or more measurements aredetermined based on a predefined dimension of the guide device.

In embodiments of the method, the guide device on the patient's backsidedefines a location and an angle of entry of the medical element into thepatient's body.

In embodiments of the method, the medical element comprises a needle.

As will be understood from the present disclosure another aspect of theinvention provides for a device for guiding medical element insertion,the device comprising: a main body with a locating feature thatreferences a landmark on a patient; a head that is translatable alongthe main body in a first direction; and a medical element guide that istranslatable along the head in a second direction perpendicular to thefirst direction, wherein the medical element guide is configured toidentify the entry location and angle of insertion of a medical elementinto the patient.

In embodiments of the device, the main body is arced with a radius ofcurvature.

In embodiments of the device, the locating feature depends downward fromthe main body; the landmark comprises the patient's coccyx; and thelocating feature is configured to be located against the patient'scoccyx when the device is placed on the patient's backside.

In embodiments of the device, the landmark comprises a locating elementaffixed to the patient; and the locating feature comprises a portion ofthe device that connects to the locating element. In embodiments of thedevice, the locating element comprises a radiopaque marker.

In embodiments of the device, the medical element comprises a needle.

In embodiments of the device, the entry location and angle of themedical element into the patient are configured to cause the medicalelement to pass through a selected foramen in the patent's sacrum.

In embodiments of the device, the medical element guide defines pluraldifferent angles for the angle of insertion of the medical element intothe patient. In embodiments of the device, the plural different anglescomprise plural different predefined angles that are defined by pluralgrooves in the medical element guide. In embodiments of the device, theplural different angles are defined by plural rotational locations ofthe medical element guide relative to the head.

As will be understood from the present disclosure another aspect of theinvention provides for a computer program product comprising one or morecomputer readable storage media having program instructions collectivelystored on the one or more computer readable storage media, where theprogram instructions are executable to: receive at least one image of asacrum of a patient; display the at least one image; receive user inputdefining points of interest in the displayed at least one image;determine one or more measurements for a medical element guide based onthe points of interest and a predefined dimension of the medical elementguide; and output the determined one or more measurements to a user.

In embodiments of the computer program product the points of interestinclude: a first point at a tip of the patient's coccyx or otherlandmark; and a second point at a foramen in the patient's sacrum. Inembodiments of the computer program product the points of interestfurther include: a third point at an intersection of a surface of thepatient's skin and a first line extending from the first point; and afourth point at an intersection of the surface of the patient's skin anda second line extending from the second point.

In embodiments of the computer program product the medical guide elementis configured to define a location and angle of insertion of a medicalelement into the patient while the medical guide element is located onthe patient's backside.

Additional aspects of the invention include manufacturing and/or usingthe device 805 or 1105 as described herein. Even further aspects of theinvention include providing instructions for using the device 805 or1105 as described herein. The instructions may be at least one ofprinted and video.

Additional aspects of the invention include a training platform. Inembodiments, the training platform is a software platform for doctors,sales reps, or any other person that needs to learn or practice theinvented technique/method. The software platform allows users to uploadmock patients and go through the measurement process, e.g., at steps 210and 215. The software can be configured to grade the user on theaccuracy of their user inputs and offer suggestions and tip on how toimprove user input. The platform can be used to train and certify usersvirtually. The platform administrator can deploy training modules andupdates to train and update users on the best practices. The platformadministrator can also collect data on user experience and interaction.The platform can provide educational animations for various processesand procedures. Future data collection may be employed in this platformof later processing and optimization.

Additional aspects of the invention include a training model. Inembodiments, the training model is a physical model used to traindoctors, sales reps, physician assistances, nurses, etc., using themethods and devices 805 and/or 1105. The training model allows users topractice placement of the sacral lead alone or in use with the virtualtraining platform. In embodiments, the training model includes thesacral bone structure as well as surrounding bone and tissue structureimportant to this procedure. In embodiments, the training model includesa soft tissue simulating structure where the opacity can be adjusted tocontrol internal visualization allowing users to block or see within themodel. In embodiments, the training model includes targets that can behit to confirm property placement of the leads. When a target is hit asignal can be produced to confirm the proper placement. Additionally,the model anatomy can be adjusted to different levels to practice ondifferent anatomies. This may be achieved by changing bone placement tochange the dimensions needed to place the stimulator. This may also beachieved with different physical models altogether to representdifferent case complexities and scenarios.

Additional aspects of the invention include an artificial intelligence(AI) platform. In embodiments, AI platform is configured to collectX-ray, measurement, and lead placement data that is achieved by thesoftware platform, success rate of patients, etc., and to use thisinformation to optimize placements and to create machine learning toautomatically identify points of interest placements and resultingmeasurements. This data can be used to predict and optimize placement ofleads resulting in more efficient conversions to full implants.

A computer program product embodiment (“CPP embodiment” or “CPP”) is aterm used in the present disclosure to describe any set of one, or more,storage media (also called “mediums”) collectively included in a set ofone, or more, storage devices that collectively include machine readablecode corresponding to instructions and/or data for performing computeroperations specified in a given CPP claim. A “storage device” is anytangible device that can retain and store instructions for use by acomputer processor. Without limitation, the computer readable storagemedium may be an electronic storage medium, a magnetic storage medium,an optical storage medium, an electromagnetic storage medium, asemiconductor storage medium, a mechanical storage medium, or anysuitable combination of the foregoing. Some known types of storagedevices that include these mediums include: diskette, hard disk, randomaccess memory (RAM), read-only memory (ROM), erasable programmableread-only memory (EPROM or Flash memory), static random access memory(SRAM), compact disc read-only memory (CD-ROM), digital versatile disk(DVD), memory stick, floppy disk, mechanically encoded device (such aspunch cards or pits/lands formed in a major surface of a disc) or anysuitable combination of the foregoing. A computer readable storagemedium, as that term is used in the present disclosure, is not to beconstrued as storage in the form of transitory signals per se, such asradio waves or other freely propagating electromagnetic waves,electromagnetic waves propagating through a waveguide, light pulsespassing through a fiber optic cable, electrical signals communicatedthrough a wire, and/or other transmission media. As will be understoodby those of skill in the art, data is typically moved at some occasionalpoints in time during normal operations of a storage device, such asduring access, de-fragmentation or garbage collection, but this does notrender the storage device as transitory because the data is nottransitory while it is stored.

In embodiments, an application (e.g., software) as described herein maycomprise computing code stored on a computer readable storage medium andexecuted by processing circuitry of a computing device (e.g., computingdevice 700) to perform the functions described herein. The computingcode may include routines, programs, objects, components, logic, datastructures, and so on that perform particular tasks or implementparticular data types that the code uses to carry out the functions ofembodiments of the invention as described herein.

It is noted that the foregoing examples have been provided merely forthe purpose of explanation and are in no way to be construed as limitingof implementations of the present invention. While aspects of thepresent invention have been described with reference to an exemplaryembodiment, it is understood that the words which have been used hereinare words of description and illustration, rather than words oflimitation. Changes may be made, within the purview of the appendedclaims, as presently stated and as amended, without departing from thescope and spirit of the present disclosure in its aspects. Althoughimplementations of the present invention have been described herein withreference to particular means, materials and embodiments,implementations of the present invention are not intended to be limitedto the particulars disclosed herein; rather, implementations of thepresent invention extend to all functionally equivalent structures,methods and uses, such as are within the scope of the appended claims.

What is claimed:
 1. A method, comprising: determining one or moremeasurements from at least one image of a sacrum of a patient; applyingthe determined one or more measurements with a guide device; locatingthe guide device on the patient's backside using a landmark; and whilethe guide device is located on the patient's backside, using the guidedevice to guide insertion of a medical element into the patient.
 2. Themethod of claim 1, wherein: the guide device is adjustable; and applyingthe determined one or more measurements with the guide device comprisesadjusting the guide device based on the one or more measurements.
 3. Themethod of claim 1, wherein the landmark comprises the patent's coccyx.4. The method of claim 1, wherein the landmark comprises a locatingelement affixed to the patient.
 5. The method of claim 1, wherein the atleast one image comprises an image of a pelvis of the patient in alateral plane.
 6. The method of claim 5, wherein the at least one imagecomprises an image of the pelvis of the patient in a posterior-anteriorplane or an anterior posterior plane.
 7. The method of claim 5, whereinthe at least one image comprises an X-ray or a CT scan.
 8. The method ofclaim 1, wherein the one or more measurements are determined based onuser input defining points of interest in the at least one image.
 9. Themethod of claim 8, wherein the points of interest in the at least oneimage comprise a location of a foramen in the sacrum.
 10. The method ofclaim 8, wherein the one or more measurements are determined based on apredefined dimension of the guide device.
 11. The method of claim 1,wherein the guide device on the patient's backside defines a locationand an angle of entry of the medical element into the patient's body.12. The method of claim 1, wherein the medical element comprises aneedle.
 13. A device for guiding medical element insertion, the devicecomprising: a main body with a locating feature that references alandmark on a patient; a head that is translatable along the main bodyin a first direction; and a medical element guide that is translatablealong the head in a second direction perpendicular to the firstdirection, wherein the medical element guide is configured to identifythe entry location and angle of insertion of a medical element into thepatient.
 14. The device of claim 13, wherein the main body is arced witha radius of curvature.
 15. The device of claim 13, wherein: the locatingfeature depends downward from the main body; the landmark comprises thepatient's coccyx; and the locating feature is configured to be locatedagainst the patient's coccyx when the device is placed on the patient'sbackside.
 16. The device of claim 13, wherein: the landmark comprises alocating element affixed to the patient; and the locating featurecomprises a portion of the device that connects to the locating element.17. The device of claim 13, wherein the medical element comprises aneedle.
 18. The device of claim 13, wherein the entry location and angleof the medical element into the patient are configured to cause themedical element to pass through a selected foramen in the patent'ssacrum.
 19. The device of claim 13, wherein the medical element guidedefines plural different angles for the angle of insertion of themedical element into the patient.
 20. The device of claim 19, whereinthe plural different angles comprise plural different predefined anglesthat are defined by plural grooves in the medical element guide.
 21. Thedevice of claim 19, wherein the plural different angles are defined byplural rotational locations of the medical element guide relative to thehead.
 22. The device of claim 16, wherein the locating element comprisesa radiopaque marker.
 23. A computer program product comprising one ormore computer readable storage media having program instructionscollectively stored on the one or more computer readable storage media,the program instructions executable to: receive at least one image of asacrum of a patient; display the at least one image; receive user inputdefining points of interest in the displayed at least one image;determine one or more measurements for a medical element guide based onthe points of interest and a predefined dimension of the medical elementguide; and output the determined one or more measurements to a user. 24.The computer program product of claim 23, wherein the points of interestinclude: a first point at a tip of the patient's coccyx or otherlandmark; and a second point at a foramen in the patient's sacrum. 25.The computer program product of claim 24, wherein the points of interestfurther include: a third point at an intersection of a surface of thepatient's skin and a first line extending from the first point; and afourth point at an intersection of the surface of the patient's skin anda second line extending from the second point.
 26. The computer programproduct of claim 23, wherein the medical guide element is configured todefine a location and angle of insertion of a medical element into thepatient while the medical guide element is located on the patient'sbackside.